The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)

June 26, 2013 updated by: Janssen Research & Development, LLC

A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar) control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy with metformin and pioglitazone to control their diabetes. Approximately 360 patients with T2DM who are receiving combination therapy with metformin and pioglitazone will receive the addition of once-daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 26 weeks followed by a 26-week extension period where patients treated with canagliflozin (100 mg or 300 mg) will continue treatment for an additional 26 weeks and patients treated with placebo will be switched to active double-blind treatment with sitagliptin 100 mg, an antihyperglycemic agent administered once-daily for 26 weeks. In addition, all patients will take protocol specified stable doses of metformin and pioglitazone along with assigned study drug for the duration of the study. Patients will participate in the study for approximately 59 to 78 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with glimepiride (rescue therapy) in accordance with local prescribing information. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self-monitored blood glucose (SMGB) measurements. The primary outcome measure in the study is the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. Patients will take single-blind placebo capsules for 2 weeks before randomization. After randomization, patients will take double-blind canagliflozin (100 mg or 300 mg) for 52 weeks OR placebo for 26 weeks switched to double-blind sitagliptin 100 mg for 26 weeks.

Study Type

Interventional

Enrollment (Actual)

344

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Calgary, Canada
      • Mount Pearl, Canada
      • Truro, Canada
    • New Brunswick
      • Bathurst, New Brunswick, Canada
      • Moncton, New Brunswick, Canada
    • Newfoundland and Labrador
      • Grand Falls-Windsor, Newfoundland and Labrador, Canada
    • Ontario
      • Brampton, Ontario, Canada
      • Hamilton, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Smiths Falls, Ontario, Canada
      • Thornhill, Ontario, Canada
    • Quebec
      • Drummondville, Quebec, Canada
  • Finland
      • Kuopio, Finland
      • Oulu, Finland
      • Turku, Finland
  • France
      • Bondy Cedex, France
      • Le Creusot, France
      • Narbonne Cedex, France
  • Germany
      • Aschaffenburg, Germany
      • Mainz, Germany
      • Neuwied, Germany
      • Schkeuditz, Germany
  • Greece
      • Athens, Greece
      • Thessaloniki, Greece
      • Thessalonikis, Greece
  • India
      • Ahmedabad, India
      • Belgaum, India
      • Chennai, India
      • Coimbatore, India
      • Jaipur, India
      • Nagpur, India
  • Mexico
      • Chihuahua, Mexico
      • Ciudad Juarez, Mexico
      • Durango, Mexico
      • Mexico, Mexico
  • Spain
      • Almería, Spain
      • Madrid, Spain
      • Sevilla, Spain
  • Thailand
      • Bangkok, Thailand
      • Khon Kaen, Thailand
  • United Kingdom
      • Antrim, United Kingdom
      • Belfast, United Kingdom
  • United States
    • Alabama
      • Anniston, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Burlingame, California, United States
      • Encinitas, California, United States
      • Fullerton, California, United States
      • Roseville, California, United States
      • Santa Ana, California, United States
      • Wes Hills, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Florida
      • Bartow, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • Pembroke Pines, Florida, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Minnesota
      • Chaska, Minnesota, United States
    • Mississippi
      • Picayune, Mississippi, United States
    • Montana
      • Billings, Montana, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Hickory, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Dublin, Ohio, United States
      • Perrysburg, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
      • Yukon, Oklahoma, United States
    • Pennsylvania
      • Bensalem, Pennsylvania, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Dallas, Texas, United States
      • Grand Prairie, Texas, United States
      • Houston, Texas, United States
      • New Braunfels, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Falls Church, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Federal Way, Washington, United States
      • Selah, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients must have a diagnosis of T2DM and be currently treated with PPAR gamma agent ((pioglitazone or rosiglitazone) and another anti-diabetes agent (metformin)
  • Patients in the study must have a HbA1c between >=7 and <=10.5% and a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

Exclusion Criteria:

  • History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • or a severe hypoglycemic episode within 6 months before screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Placebo/Sitagliptin
Each patient will receive matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients will be switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
Drug: Placebo
One matching placebo capsule orally (by mouth) once daily for 26 weeks with stable doses of metformin and pioglitazone.
Drug: Sitagliptin
One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 with stable doses of metformin and pioglitazone.
Drug: Metformin
The patient's stable dose of metformin background therapy should be continued throughout the study.
Drug: Pioglitazone
The patient's stable dose of pioglitazone background therapy should be continued throughout the study.
Experimental: Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Drug: Metformin
The patient's stable dose of metformin background therapy should be continued throughout the study.
Drug: Pioglitazone
The patient's stable dose of pioglitazone background therapy should be continued throughout the study.
Drug: Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone.
Experimental: Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Drug: Metformin
The patient's stable dose of metformin background therapy should be continued throughout the study.
Drug: Pioglitazone
The patient's stable dose of pioglitazone background therapy should be continued throughout the study.
Drug: Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 26
Time Frame: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With HbA1c <7% at Week 26
Time Frame: Week 26
The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Week 26
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Time Frame: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26
Time Frame: Day 1 (Baseline) and Week 26
HOMA2-%B is a measure of beta cell function (the cells in the pancreas that produce and store insulin). The table below shows the least-squares (LS) mean change in HOMA2-%B from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Percent Change in Body Weight From Baseline to Week 26
Time Frame: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Day 1 (Baseline) and Week 26
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Time Frame: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Percent Change in Triglycerides From Baseline to Week 26
Time Frame: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Day 1 (Baseline) and Week 26
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Time Frame: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Day 1 (Baseline) and Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

April 16, 2010

First Posted (Estimate)

April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

July 15, 2013

Last Update Submitted That Met QC Criteria

June 26, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017032
  • 28431754DIA3012 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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